New Approach Uses Smartphone App to Remotely Quantify Time-Related Adverse Symptoms in RA Patients Related to Methotrexate Administration

UPPER NYACK, NY – (COMMERCIAL THREAD)–Today CreakyJoints®, the international digital patient community for people with all forms of arthritis and part of the Global Healthy Living Foundation, announced the publication of a new peer-reviewed article describing how their ArthritisPower mobile app can be used to capture experiences reported by patients. on a rheumatic disease medicine such as methotrexate (MTX), specifically for short-term symptoms that are temporally related to the administration of the dose. Researchers have found that nearly two-thirds of patients with rheumatoid arthritis (RA) and psoriatic arthritis (RP) experience side effects from methotrexate (including fatigue and nausea) and that for many, the experience of these symptoms is much more intense over the course of 1-2 days. after each weekly dose is taken. The unique design of this study which compares the symptoms of patients measured within 1-2 days after taking MTX with their symptoms measured several days later demonstrates the great value of a smartphone-based strategy for remote therapeutic monitoring. . It also demonstrates that using digital technology to assess drug-related symptoms is both feasible and acceptable to patients. The study, “Patient-Reported Nausea and Fatigue Related to Methotrexate: A Prospective, Self-Monitoring Study in the ArthritisPower® Register ”, was published in Rheumatology and therapy (November 28, 2021).

Previous studies have confirmed that the Patient-Reported Outcome Measurement Information System (PROMIS) developed by the National Institutes of Health reliably captures important patient experiences in the areas of physical, mental and social health. . Dozens of PROMIS measurements are available in CreakyJoints’ ArthritisPower Research Registry, which researchers in this study used to collect information about patient experiences with treatment with MTX, a commonly prescribed drug for RA, RP and other forms of autoimmune arthritis. MTX has a reasonable efficacy and safety profile that has been well documented in previous studies, but is known to induce unwanted symptoms in some patients who take it.

“In this study, we used a self-monitoring case series study design using electronic measures of patient-reported outcomes (e-PROM) to generate concrete evidence regarding patient experiences and side effects of the drug. processing. We found that the majority of current MTX users report side effects, such as fatigue and nausea, with average changes in these symptoms measured shortly after each weekly dose exceeding a minimally significant difference (MID), ” said W. Benjamin Nowell, PhD, Director, Patient-Centered Research, CreakyJoints and Principal Investigator of ArthritisPower. “While these results are not particularly surprising and serve to reinforce the conclusions of previous research, it should be noted that we were able to measure the evolution of symptoms which fluctuate noticeably during the week depending on the time of use. of MTX. While the patient-provider interactions that occur during traditional office visits can gauge a drug’s effectiveness in improving disease activity over weeks and months, they can miss the mark to capture the real experience. of patients taking medicines which may have unwanted side effects which vary widely depending on until when the treatment is taken. If the side effects are perceived by the patient as unmanageable, then the patients will forgo the drug, which will increase the risk of the disease getting worse or having complications.

Dr Nowell is also the co-author of a recently published article in Musculoskeletal care (December 8, 2021) titled “The Development and Validation of a Patient Perceived Methotrexate Intolerance Scale for Use in Adult Patients with Rheumatoid Arthritis”, which is the first known scale with favorable measurement properties to assess methotrexate intolerance in adults using a patient-centered perspective.

Measurement of Adverse Symptoms Time-Related to MTX Dose Administration

In the Rheumatology and therapy study, 85 current MTX users provided regular e-PROM data within a week of dosing related to nausea or fatigue, which correlated onset and severity of side effects with time of weekly administration. Of the participants, 39.8 percent were on a biological DMARD and 59.3 percent were on a non-biological DMARD only. Among participants reporting baseline nausea associated with MTX, 41 percent (16/39) experienced worsening nausea using a 3-unit MID. Among participants reporting baseline MTX-associated fatigue, 41 percent (21/51) experienced worsening fatigue using a 3-unit MID. Using an alternative threshold for MID of 5 units, the corresponding proportions were 31 percent (12/39) for nausea and 39 percent (20/51) for fatigue. Net, about a third of the patients in this sample experienced significant worsening of nausea or fatigue within one day of their weekly dose of MTX, with an amplitude of change exceeding the MID.

“By stratifying the results by self-reported symptoms measured before the start of the assessment, we were able to quantify the severity of important symptoms that bother a large minority of patients. These important observations would have been obscured if they were only reported at the group level. The results of this study also provide evidence for the convergent validity of the specific PROMIS instruments used in this study, which have not been previously evaluated in patients with RA, ”said Dr. Jeff Curtis, MD, MS, MPH , Marguerite Jones Harbert – Gene V. Ball Professor of Medicine in Rheumatology and Immunology at the University of Alabama at Birmingham and Co-Principal Investigator of the ArthritisPower Registry.

Dr Curtis continued, “The magnitude and frequency of side effects associated with MTX over time in rheumatoid arthritis patients have been difficult to quantify in the past because traditional assessments are collected in the office. This study demonstrates that patients are open to monitoring their treatment experience and associated symptoms, remotely, using a smartphone app, providing researchers with new insight into the extent of significant side effects that can potentially occur. have an impact on adherence. More and more patients and providers are feeling comfortable with virtual telehealth appointments and remote patient and therapy monitoring. It is increasingly clear that being able to capture PRO data digitally will be essential to understanding each patient’s arthritis experience and management.

In this study, participants were recruited from the ArthritisPower Patient-Powered Research Network Registry. To be eligible for the study, participants in ArthritisPower must be residents of the United States aged 19 and over (or 21 years of age if they are from Puerto Rico), with a self-reported diagnosis of RA or PsA. by a doctor. After completing a screening questionnaire to determine further eligibility, patients currently taking oral MTX were invited to participate in the longitudinal study, which required at least 1 dose taken within the previous month and use. of MTX for less than 10 years. In the absence of data indicating a tolerance threshold for the duration of treatment with MTX, the 10-year limit was chosen to strike a balance between a possible adjustment of tolerance to MTX over time and allowing adequate participation in investigation. The use of MTX was allowed either alone (i.e. as monotherapy) or in combination with other DMARDs.

This study was sponsored by Amgen Inc.

About ArthritisPower

Created by CreakyJoints®, ArthritisPower® is the first ever patient-centered research registry for joints, bones, and inflammatory skin conditions, as well as arthritis and rheumatologic manifestations of the gastrointestinal (GI) tract and skin conditions. With tens of thousands of consenting arthritis patients, the free ArthritisPower desktop and mobile app enables patients to track their disease and participate in voluntary research studies in a secure and accessible manner. The results of ArthritisPower studies are frequently published in peer-reviewed journals and presented at medical meetings in the United States and around the world. ArthritisPower’s patient governors serve as gatekeepers for researchers seeking access to registry data or soliciting the community to participate in unique voluntary studies. To learn more and join ArthritisPower, visit

About CreakyJoints

CreakyJoints® is a digital community for millions of arthritis patients and caregivers around the world seeking education, support, advocacy and patient-centered research. We represent patients in English and Spanish through our popular social media channels, websites and the 50 State Network, which includes more than 1,600 trained patient volunteers, caregivers and healthcare activists.

Part of the Global Healthy Living Foundation, CreakyJoints also has a patient-reported results registry called ArthritisPower® (, which includes tens of thousands of consenting arthritis patients who are monitoring their disease while also volunteering. to participate in longitudinal and observational research. CreakyJoints publishes the popular Raising the Voice of Patients series, which provides downloadable patient-centered educational and navigation tools for chronic disease management. It also hosts PainSpot (, a digital risk assessment tool for musculoskeletal disorders and injuries, and eRheum (, for telehealth and virtual care support. All programming is free, always. For more information and to become a member, visit

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